Antisense Therapeutics (ASX:ANP) says it continues to interact with potential pharmaceutical partners regarding the ongoing development of ATL1102 for Multiple Sclerosis.
In a statement, the company managing director and CEO, Mark Diamond, along with other representatives of the company attended a number of meetings in the US in September 2016 relating to the 'ATL1102 for MS' project.
"The Company remains firmly of the belief that ATL1102 in MS is a program that justifies continued development and an asset that should be attractive to potential pharmaceutical partners," it said.
"In parallel with the partnering interactions, given the protracted nature of this process and timeline that is outside of the Company’s direct control, ANP continues to add value and move this program forward by preparing Investigational New Drug (IND) submission to the US Food and Drug Administration (FDA), seeking other development opportunities and progressing non-dilutive funding initiatives for the conduct of the Phase IIb trial.
"Phase IIb Investigational New Drug (IND) submission and non-dilutive funding The Company’s IND application for a Phase IIb trial in 195 MS patients is in its final stages of preparation."
The company said the submission to the FDA is now forecast for early 2017 due to delays encountered with the relevant authorities issuing of the requisite permits for the shipment of samples of monkey plasma from China to the US so that pharmacokinetic data can be generated from a previously conducted animal toxicology study for inclusion in the IND application.
"These permits have now been issued and the samples shipped for analysis," it said.
Antisense said it expects an IND clearance for a Phase IIb trial of ATL1102 would enhance its commercialisation efforts.
"With the assistance of consulting firm FreeMind who specialise in helping life science organisations secure non-dilutive funding from US Federal Agencies and Private Foundations, the Company anticipates making an application after IND clearance for an appropriate award grant that has been identified of the type and size (>US$10 million) that would fund the conduct of the Phase IIb trial."
The company said it is also proposing to undertake a smaller (approximately 12 patients) investigative study of ATL1102 in relapsing SP-MS patients in Germany with Professor Volker Limmroth (Cologne City Hospital, Department of Neurology, Germany), the Principal Investigator of our successful Phase IIa study.
In August 2016, an application was submitted to the National Multiple Sclerosis Society in the US for grant funding to conduct this study.
"The notice of successful grants is expected in February 2017, which could allow for a potential study start in early Q2’17," said the company.